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SSH ISO 18362:2016/Amd 1:2022

Manufacture of cell-based health care products - Control of microbial risks during processing - Amendment 1

Sep 29, 2023

General information

60.60     Sep 29, 2023

DPS

DPS/KT 205

International Standard

11.080.01  

English  

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Scope

ISO 18362:2016 specifies the minimum requirements for, and provides guidance on, a risk-based approach for the processing of cell-based health care products (CBHPs) requiring control of viable and non-viable microbial contamination. It is applicable both to CBHPs labelled 'sterile' and to CBHPs not labelled 'sterile'.

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PUBLISHED
SSH ISO 18362:2016/Amd 1:2022
60.60 Standard published
Sep 29, 2023